Events

Recall of Colleague 3 Volumetric Infusion Pumps

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28824
  • Event Risk Class
    Class 2
  • Event Number
    Z-0880-04
  • Event Initiated Date
    2004-04-13
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32710
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, Infusion - Product Code FRN
  • Reason
    Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.
  • Action
    Baxter sent urgent device correction letters dated 4/13/04 to the direct accounts to the attention of the Director of Biomedical Engineering on the same date. The letters informed the accounts of the ink deterioration of the letters, numbers and symbols on the Colleague Volumetric Infusion Pump programming and pump channel keypads, and informed them that over time such ink deterioration may impact legibility of the keys. The letters provided a listing of model numbers and serial numbers of pumps at their facility which may have potentially affected keypads. The accounts were given a sample of the overlay to be applied over the programming keypad and installation instructions as an interim fix while replacement keypads are obtained and installed as the pumps are processed through their depot repair centers. The accounts were requested to complete the attached reply form and return it via fax to Baxter. The completed form acknowledges receipt of the recall letter, verifies the model numbers and serial numbers of the pumps at the facility and indicates the number of overlays needed. Any questions were directed to Baxter at 1-800-843-7867. On 6/9/05, Baxter sent Urgent Device Correction letters to the accounts, to the attention of the Director of Biomedical Engineering, advising them that the replacement pump programming and pump channel keypads were now available.

Device

Colleague 3 Volumetric Infusion Pumps
  • Model / Serial
    product code 2M8153 - serial numbers 12110481CT and above; product code 2M8153K - serial numbers 12120001TK and above
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, and internationally to Australia, the Bahamas, Belgium, Brazil, Canada, Colombia, El Salvador, Guatemala, Honduras, Israel, Lebanon, Mexico, New Zealand, Panama, the Philippines, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates and the United Kingdom.
  • Product Description
    Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153K (United Kingdom); Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; monochrome display screen
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA